TY - JOUR
T1 - Evaluating enrollment and outcome criteria in trials of biologics for chronic rhinosinusitis with nasal polyps
AU - Borish, Larry
AU - Cohen, Noam A.
AU - Chupp, Geoffrey
AU - Hopkins, Claire
AU - Wagenmann, Martin
AU - Sousa, Ana R.
AU - Smith, Steven G.
AU - Silver, Jared
AU - Yang, Shibing
AU - Mayer, Bhabita
AU - Yancey, Steven W.
AU - Chan, Robert H.
AU - Fokkens, Wytske
N1 - Funding Information: Editorial support was provided by Alice Rees, PhD, at Fishawack Indicia Ltd, United Kingdom, part of Fishawack Health, under the direction of the authors, and was funded by GlaxoSmithKline. Disclosures: Dr Borish reports having participated in advisory boards and receiving honoraria from Regeneron Pharmaceuticals, DevPro Biopharma, GlaxoSmithKline, and AstraZeneca and receiving clinical research grants from GlaxoSmithKline and Regeneron Pharmaceuticals. Dr Cohen has reported receiving personal fees from Novartis and Sanofi and Regeneron Pharmaceuticals and having Licensing of Patent rights namely GeneOne Life Sciences. Dr Chupp has acted as a consultant for AstraZeneca, Genentech, Boehringer Ingelheim, and Teva; attended a speaker's bureau with AstraZeneca, Genentech, and Circassia; and received research grants from AstraZeneca and institutional grants from AstraZeneca, Genentech, Boehringer Ingelheim, and GlaxoSmithKline. Dr Hopkins has reported receiving personal fees from Sanofi, AstraZeneca, Olympus, and GSK, and Mylan. Dr Wagenmann reports receiving personal fees from ALK-Abelló, Allergopharma, AstraZeneca, Bencard Allergie, Genzyme, HAL Allergie, Infectopharm, LETI Pharma, MEDA Pharma, Novartis, Sanofi Aventis, Stallergenes, and Teva. Dr Fokkens reports that the Department of Otorhinolaryngology of the Amsterdam University Medical Centres, location AMC received grants from GSanofi, Mylan, ALK-Abelló, Allergy Therapeutics, Novartis, and Chordate and that she has received personal fees from GlaxoSmithKline, Sanofi, and Lyra Therapeutics. Dr Sousa, Dr Smith, Dr Silver, Dr Yang, Dr Mayer, Dr Yancey, and Dr Chan are employees of GlaxoSmithKline and own stocks and shares. Funding: The SYNAPSE study discussed in this article was funded by GlaxoSmithKline (GSK ID: 205687). Funding Information: Funding: The SYNAPSE study discussed in this article was funded by GlaxoSmithKline (GSK ID: 205687). Publisher Copyright: © 2022 The Authors
PY - 2022/8
Y1 - 2022/8
N2 - Objective: Treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) generally involves intranasal corticosteroids (INCS) and saline irrigation, followed by short courses of systemic corticosteroids (SCS) or surgery with postoperative medical therapy for patients who do not respond to INCS. However, both SCS use and surgery are associated with a range of adverse effects or complications, have a high recurrence rate, and are unsuitable for some patients. Biologics targeting the underlying pathophysiology are promising treatment alternatives for these patients. Dupilumab, omalizumab, and mepolizumab are approved for use in patients with severe, uncontrolled CRSwNP. However, the lack of a consistent definition of severe CRSwNP makes the decision to initiate biologic treatment particularly complex. Furthermore, the position of each biologic in the overall management of CRSwNP remains to be clarified. Data Sources: Publications reporting results of phase III trials of dupilumab, omalizumab, mepolizumab, and benralizumab in the treatment of CRSwNP. Study Selections: Randomized, controlled phase III trials of biologics approved for CRSwNP. Results: These trials all used different enrollment criteria. We discuss the complexities of assessing CRSwNP disease severity and highlight how these impact comparisons of the populations and outcomes of the phase III biologic trials. Conclusion: To position biologic agents appropriately within the existing CRSwNP treatment paradigm, future trials will need to include comparable patient populations and standardized outcome measures. Such trials will help to ensure that biologic treatment is targeted appropriately to support optimal clinical outcomes.
AB - Objective: Treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) generally involves intranasal corticosteroids (INCS) and saline irrigation, followed by short courses of systemic corticosteroids (SCS) or surgery with postoperative medical therapy for patients who do not respond to INCS. However, both SCS use and surgery are associated with a range of adverse effects or complications, have a high recurrence rate, and are unsuitable for some patients. Biologics targeting the underlying pathophysiology are promising treatment alternatives for these patients. Dupilumab, omalizumab, and mepolizumab are approved for use in patients with severe, uncontrolled CRSwNP. However, the lack of a consistent definition of severe CRSwNP makes the decision to initiate biologic treatment particularly complex. Furthermore, the position of each biologic in the overall management of CRSwNP remains to be clarified. Data Sources: Publications reporting results of phase III trials of dupilumab, omalizumab, mepolizumab, and benralizumab in the treatment of CRSwNP. Study Selections: Randomized, controlled phase III trials of biologics approved for CRSwNP. Results: These trials all used different enrollment criteria. We discuss the complexities of assessing CRSwNP disease severity and highlight how these impact comparisons of the populations and outcomes of the phase III biologic trials. Conclusion: To position biologic agents appropriately within the existing CRSwNP treatment paradigm, future trials will need to include comparable patient populations and standardized outcome measures. Such trials will help to ensure that biologic treatment is targeted appropriately to support optimal clinical outcomes.
UR - http://www.scopus.com/inward/record.url?scp=85130360297&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.anai.2022.04.004
DO - https://doi.org/10.1016/j.anai.2022.04.004
M3 - Review article
C2 - 35398492
SN - 1081-1206
VL - 129
SP - 160
EP - 168
JO - Annals of allergy, asthma & immunology
JF - Annals of allergy, asthma & immunology
IS - 2
ER -